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Would you like to join an international team working to improve the future of healthcare?
Grifols is a global healthcare company that since **** has been working to improve the health and well-being of people around the world.
We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
At Grifols, we believe that diversity adds value to our business, our teams, and our culture.
We are committed to equal employment opportunities that foster an inclusive environment.
Position Summary
The Validation Engineer will write, review and execute Validation Plans, Protocols and Reports for Secondary Packaging Projects and Revalidations ensuring compliance to all relevant global and local quality and validation procedures/standards.
Initial requirements focus on Packaging Equipment Qualification and Temperature Mapping with Utilities, Cleaning Revalidation to follow.
Represent Validation at technical forums including external and internal audits.
Responsibilities
Write, review and execute Validation Protocols and Reports (for Equipment, Utilities, Processes, Cleaning, Temperature Mapping and Equipment Software) ensuring compliance to all relevant global and local quality and validation procedures/standards
Represent Validation at both internal and external audits by regulatory agencies, including HPRA and FDA
Generation and review of project documentation (User Requirement Specifications, validation protocols, reports etc.) and Standard Operating Procedures
Support validation activities including review of documentation and hands-on execution of validation activities (FAT, SAT, IQ, OQ, PQ etc) to ensure equipment meets current GMP requirements and industry standards
Demonstrates technical knowledge and ability to adapt to changing circumstances.
Works with Operations, Quality, and Maintenance to execute qualification and validation efforts in support of site projects
Completion of risk assessments, closure of corrective and preventive actions (CAPA)
Investigates and troubleshoots problems and determines solutions or recommendations for changes and/or improvements
Performs other validation-associated activities as defined by Manager or Director
Key competencies
Packaging Equipment Qualification
Temperature Mapping
Computer System Validation
Clean Utilities
Cleaning Validation
Commissioning and Qualification
Documentation (Writing SOPs, Protocols, Reports)
Auditing
Strong communication / presentation skills during internal/external audits
Person specification / Qualifications
Project Management Experience
Hands-on knowledge of execution of Validation
Experience in a Quality or Validation Role within Pharma sector
Experience with Software validation for manufacturing
Excellent Technical Writing and analytical skills
Familiarity with cGMPs and industry/federal guidelines
Experience with Word, Excel and Access
Strong interpersonal skills for interactions with other departments
Degree in Science/Engineering and/or minimum 4 years Validation experience
Experience representing client companies during internal and external audits (FDA/HPRA)
Working knowledge of HTM 01 (Part C, Steam Sterilization) Autoclaves
Familiarity with ISO-***** (Cleanrooms) and Annex 1 (Sterile Manufacturing)
Experience within aseptic manufacturing environment
Our benefits
Highly competitive salary
Group pension scheme with company matching
Private Medical Insurance for the employee
Ongoing opportunities for career development
Succession planning and internal promotions
Education allowance
Wellness activities and social events
We understand that self-doubt can hold talented individuals back from applying for opportunities.
We encourage everyone who meets the qualifications to apply – we're excited to hear from you.
Grange Castle International Business Park, Grange, Co.
Dublin, D22 K2R3
Details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Quality Assurance
Industries: Pharmaceutical Manufacturing and Medical Equipment Manufacturing
Learn more about Grifols
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